Radiopharmaceuticals developer Navidea Biopharmaceuticals (NYSE Amex:NAVB) said early results from a phase 3 clinical study suggest that a targeting agent from the company could be effective in detecting head and neck cancer.
Dublin, Ohio-based Navidea recently presented interim results from a head and neck cancer trial of its drug Lymphoseek, a targeting agent used by surgeons to identify lymph nodes in patients with breast cancer or melanoma and to indicate whether cancer has spread to a particular lymph node.
Data from nine patients suggests Lymphoseek could be used by doctors to perform the same function in patients suffering from head and neck cancer, according to a statement from Navidea (formerly known as Neoprobe).
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Further clinical testing that shows Lymphoseek to be useful in treating head and neck cancer patients could expand the market for the drug and boost its sales.
However, the company warned that the results were only interim and that they “may or may not be consistent with the complete data that will be available when the trial is completed.”
The U.S. Food and Drug Administration is expected to decide by this summer whether Lymphoseek is approved for U.S. sales and marketing for the treatment of breast cancer and melanoma. The drug has a PDUFA date of June 10, which means an FDA decision is expected roughly around that time.
The head and neck cancer clinical trial is ongoing.
Navidea has pegged Lymphoseek’s annual worldwide market potential at $450 million.
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